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Volume 7: Medicines and Cosmetics
2.
The operation of medicines licensing
Annex 1 to Chapter 2: Examples of bovine materials used in medicines
Table 1: Active ingredients
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Non Proprietary Medicinal Product (not the marketed trade names)
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Polypeptide hormone - active ingredient |
Pancreas. Purified using mild chemical &/or physical conditions |
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Anticoagulant polypeptide - active ingredient |
Various bovine tissues, mainly lung. Produced using mild chemical &/or physical conditions |
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Anticoagulant - active ingredient |
Salts of sulphated glucosaminoglycans prepared from lungs and intestinal mucosa. Highly purified using mild chemical and physical conditions |
Heparins, heparin salts (calcium and sodium), low molecular weight heparins (tinzaparin) |
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Small intestine. The raw material is processed using harsh chemical washing and irradiation to sterilise |
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Calcium supplement - drug substance |
Bone (femur). Manufactured using very harsh chemical and physical conditions |
Calcium gluconate tablets |
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Hormone/steroid treatments - active ingredients |
Adrenal glands processed to produce cortisone, hydrocortisone, aldosterone. Mild purification conditions to ensure steroid activity |
Various products as individual steroids or mixtures |
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Hormone - active ingredient for diabetes treatment |
Manufactured from pancreas. Highly processed using gentle conditions |
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Implants - drug substance |
Processed from hide using harsh physical and chemical conditions. Highly processed |
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Source: R Turner MCA DH01
tab 16
Table 2: Excipients and manufacturing ingredients
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Calf foetus. Produced using mild conditions and filter sterilisation |
Vaccines, antibodies, recombinant proteins |
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Blood. Purified using mild chemical &/or physical conditions |
Vaccines, antibodies, recombinant proteins |
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Used as a supplement during cell culture |
Blood. Produced using mild chemical and physical conditions |
Vaccines, antibodies, recombinant proteins |
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Liver. Produced using harsh chemical &/or physical conditions |
Vaccines, multi vitamin (liver extract) |
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Pancreatic enzyme used during manufacture |
Pancreas. Purified using mild physical and chemical conditions |
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Hydrolysed milk protein. Cell culture ingredient |
Milk. Produced using harsh chemical &/or physical conditions |
Vaccines, antibodies, recombinant proteins |
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Hydrolysed milk protein. Cell culture ingredient |
Milk whey. Produced using chemical &/or physical conditions |
Vaccines, antibodies, recombinant proteins |
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Milk whey. Produced using chemical &/or physical conditions |
Vaccines, antibodies, recombinant proteins |
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Excipient in manufacture. Also used as a blood volume expander |
Bones and hide. Highly processed by acid/alkaline hydrolysis - very harsh chemical and physical conditions |
Various. Capsules, pastes, pastilles, tablets and suppositories. Blood volume expander |
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Meat (skeletal and cardiac muscle). Produced using mild chemical &/or physical conditions |
Vaccines, antibodies, recombinant proteins |
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Milk whey. Produced using chemical &/or physical conditions |
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Widely used as a diluent to give bulk to powders and as a diluent in compressed tablets |
Milk. Carboyhdrate manufactured from milk using relatively mild chemical &/or physical conditions |
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Pancreatic enzyme used in production of medicinal products |
Pancreas. Manufactured using mild conditions |
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Cholic and deoxycholic acids |
Detergent used as manufacturing ingredients (viral inactivation) |
Bile. Highly processed using harsh chemical and physical conditions |
Vaccines, plasma derived medicinal products, recombinant protein products |
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Meat (skeletal and cardiac muscle). Produced using mild chemical &/or physical conditions |
Recombinant protein medicine |
Source: R Turner MCA DH01
tab 16
Table 3: Tallow derivatives
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Tallow derivative. Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed |
Various, mainly ointments |
Stearic acid and salts (magnesium/calcium) |
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Tallow derivative. Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed |
Various as excipient/manufacturing ingredient |
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Tallow derivative (detergent). Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed. |
Various as excipient/manufacturing ingredient |
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Tallow derivative. Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed. |
Various. Capsules, pastes, pastilles, tablets and suppositories |
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Tallow derivative (detergent). Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed |
Various as excipient/manufacturing ingredient |
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Tallow derivative (detergent). Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed. |
Various. Capsules, pastes, pastilles, tablets and suppositories |
Source: R Turner MCA DH01
tab 16
Table 4: Examples of medical devices utilising tissues or derivatives of animal origin
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Derivative from invertebrate source
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Bone substitute for orthopaedic fractures |
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Sutures in surgical procedures |
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subtilisin enzyme, biofermentation |
Enzyme cleanser for contact lenses |
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Hyaluronic acid, biofermentation |
Viscoelastic gel for ophthalmics |
Derivative of animal exudate or excretory product
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Wool, blended from different sources |
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Casein, ferment from the stomach |
Stabiliser in latex production |
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Lanolin, derived from sheep wool |
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Derivative of animal tissue
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Gelatine, main part of connective tissue |
Coatings, impregnations on cardiovascular devices |
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Aid to process of manufacture |
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Collagen, many structural forms |
Impregnations on range of devices, dressings |
Animal tissue as major component
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Valve leaflets, cardiovascular |
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Viscoelastic gels, ophthalmics |
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Ankle/knee support products |
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Bone structure, cancellous bone |
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DH01 tab
13 p. 6
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